FDA.reportPublic FDA data

InnovaMatrix AC

Primary DI
00850002643428
Brand
InnovaMatrix AC
Company
Triad Life Sciences, Inc.
Model
IMX-0203-01
Device description
2cm x 3cm Porcine Placenta Derived ECM
Published
2025-01-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KGNWound Dressing With Animal-Derived Material(S)

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KGNWound Dressing With Animal-Derived Material(S)UnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K193552000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193552000InnovaMatrixTriad Life Sciences, Inc.2020-10-21KGN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850002643428PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850002643428008500026434288500026434280850002643428

GMDN Terms#

Term, Definition table
TermDefinition
Collagen wound matrix dressingA sterile, bioabsorbable, animal-derived collagen protein matrix designed to provide an occlusive/semi-occlusive cover for wound healing (non-oral) and/or a skin template of living cells (fibroblasts) and/or structural proteins to facilitate the infiltration of native skin elements (e.g., fibroblasts, leukocytes, blood vessels) for skin regeneration. The device is used for various types of partial- and full-thickness wounds, draining wounds, sores/ulcers, skin lacerations/abrasions, burns, and/or surgical wounds. It may combine collagen with other compounds or supplemental dressing materials (e.g., alginate); it is supplied in various forms. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
081037338
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850002643411InnovaMatrix ACIMX-18MM-012025-01-09
00850002643435InnovaMatrix ACIMX-0304-012025-01-09
00850002643442InnovaBurnIMB-0606-012025-01-09
00850002643459InnovaBurnIMB-0707-012025-01-09
00850002643466InnovaBurnIMB-0810-012025-01-09
00850002643473InnovaBurnIMB-1012-012025-01-09
00850002643480InnovaMatrix FSIMF-0203-012025-01-09
00850002643497InnovaMatrix FSIMF-0304-012025-01-09
00850002643503InnovaMatrix FSIMF-0406-012025-01-09
00850002643268InnovaBurnIMB-0505-01IMB-0505-012022-12-21
00850002643275InnovaBurnIMB-0507-01OMB-0507-012022-12-21
00850002643282InnovaBurnIMB-0808-01IMB-0808-012022-12-21
00850002643299InnovaBurnIMB-1010-01IMB-1010-012022-12-21
00850002643305InnovaBurnIMB-1020-01IMB-1020-012022-12-21
00850002643312InnovaBurnIMB-1520-01IMB-1520-012022-12-21
00850002643367InnovaMatrix PDIMP-0050-01IMP-0050-012022-12-21
00850002643374InnovaMatrix PDIMP-0100-01IMP-0100-012022-12-21
00850002643398InnovaMatrix PDIMP-0250-01IMP-0250-012022-12-21
00850002643404InnovaMatrix PDIMP-0500-01IMP-0500-012022-12-21
00850002643336InnovaMatrix FSIMF-0202-01IMF-0202-012022-12-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810179632403OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632458OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632472OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632595OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632625OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632717OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632724OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632731OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
00810179632748OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
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00810179632762OASISCOOK BIOTECH INCORPORATEDKGN2026-07-31
09421908222515Myriad Meshed Soft Tissue BioscaffoldAROA BIOSURGERY LIMITEDKGN2026-07-04
00860012016686MaxioCel Chitosan Wound DressingAdvamedica Inc.KGN2026-06-08
00850084084010CURCOFR TECH, LLCKGN2026-06-02
00850084084027CURCOFR TECH, LLCKGN2026-06-02